Validation CSV Expert GDIT R&D and Medical (Computer System Validation)

Location: Paris, France

Company

hirify.global is a mid-sized global biopharmaceutical company developing medicines in Oncology, Rare Disease, and Neuroscience, with operations in more than 40 countries.

What you will do

• Define and lead the CSV strategy for R&D IT systems in line with GxP and FDA requirements.
• Act as the quality gatekeeper for computerized systems, ensuring validation, compliance, and continuous audit readiness.
• Oversee the full validation lifecycle, including URS, FS/DS, IQ/OQ/PQ, documentation, and periodic reviews.
• Lead audit and inspection readiness and serve as a key contact for internal and external audits.
• Embed validation requirements into system implementations and changes, manage change controls, and assess validation impacts.
• Collaborate with IT QA, Regulatory, Quality, IT, and business stakeholders.

Requirements

• 6–8 years of Computer System Validation experience in the pharmaceutical or life sciences industry.
• Strong knowledge of GxP, FDA 21 CFR Part 11, Annex 11, and GAMP5.
• Solid experience managing validation lifecycles and audit or inspection processes.
• Experience with R&D systems such as Veeva, LIMS, or ELN.
• Ability to combine strategic vision with hands-on execution in regulated environments.
• Strong stakeholder management, influencing, and transversal leadership skills.
• High rigor in documentation and compliance practices.
• Ability to communicate with regulatory authorities and audit teams.
• Fluent English required.

Culture & Benefits

• High-impact role focused on compliance of R&D digital systems.
• Strong exposure to regulatory, quality, and IT environments.
• Strategic position balancing innovation and compliance.
• Collaborative and international environment focused on patient impact and excellence.
• Inclusive workplace supporting diverse perspectives, equal opportunity, and reasonable application accommodations.